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Stock Market & Financial Investment News

News Breaks
December 2, 2013
07:33 EDTBIIBBiogen receives notification from the FDA of PDUFA date extension for ALPROLIX
Biogen Idec announced that the U.S. Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of the Biologics License Application for ALPROLIX, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B. The PDUFA date has been extended by three months, which is the standard extension period. In response to a request from FDA, Biogen Idec submitted additional information related to the validation of a manufacturing step for ALPROLIX. Due to the timing of this submission, the FDA extended the PDUFA date to allow additional time for review of the marketing application.
News For BIIB From The Last 14 Days
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April 20, 2014
16:45 EDTBIIBBiogen hemophilia drug Alprolix priced similar to older treatments, Reuters says
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April 16, 2014
08:34 EDTBIIBPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
April 14, 2014
09:46 EDTBIIBBiogen hugs support at critical technical juncture, levels to watch
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07:33 EDTBIIBBiogen to present Plegridy, Tecfidera data at AAN annual meeting
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April 11, 2014
10:15 EDTBIIBBiogen heads for test of $280 area
The shares are heading lower after an early bounce attempt and are now just above the session low at $280.13. As noted yesterday, a break below $280 would confirm topping in the shares. Support below $280 is at $273.45. Resistance is at $285.
April 10, 2014
15:13 EDTBIIBBiogen tumbles, nearing important test of support
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09:00 EDTBIIBBiogen May volatility elevated at 43 into Q1 and revenue outlook
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07:31 EDTBIIBBiogen names Adam Koppel as SVP, Chief Strategy Officer
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07:08 EDTBIIBBiogen announces positive top-line efficacy, safety results from Phase 3 trial
Biogen Idec and Swedish Orphan Biovitrum AB released positive top-line results of the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of Eloctate, an investigational recombinant factor VIII Fc fusion protein product candidate, in children with severe haemophilia A. Eloctate was generally well-tolerated and no inhibitors were detected. Efficacy analyses showed twice-weekly prophylactic dosing with Eloctate maintained low bleeding rates in children.
April 8, 2014
07:22 EDTBIIBCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.

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